Duns Number:264502977
Device Description: "LEKSELL FRAME ADAPTORinstrument Rosa One 3.1 (brain application)Mechanical adaptor to con "LEKSELL FRAME ADAPTORinstrument Rosa One 3.1 (brain application)Mechanical adaptor to connect the support arm to the leksell stereotactic frame, supplied with 8 mm hexagonal key"
Catalog Number
ROSAS00348
Brand Name
LEKSELL FRAME ADAPTOR
Version/Model Number
174017-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182417,K200511
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
db70d179-0f3c-4b67-ab8f-7224bafcfe44
Public Version Date
October 02, 2020
Public Version Number
3
DI Record Publish Date
June 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 251 |